Expert Insights On Cell Line Development
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The Hidden Engineering Behind Successful Upstream Bioprocessing
2/25/2026
In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.
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This Industrial Fungus Has Protein Expression Promise For Pharma
2/12/2026
Trichoderma reesei is well characterized for industrial uses. A Finnish research group is exploring it for pharmaceutical protein expression.
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High Specific Productivity For Leaner Sustainable Bioprocessing
1/30/2026
Improving specific productivity moves the goal beyond pumping out higher titers, but it demands a deeper understanding of cellular biology and protein expression.
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Why Use Total Organic Carbon Analysis For Cleaning Validation?
1/21/2026
Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.
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Ask The Pros — The Latest In Upstream HCP Mitigation
1/5/2026
We asked leading experts how upstream interventions can reshape HCP control. Here’s what they shared. Answers have been edited for clarity.
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An End-To-End Automated HTP Platform For Cell Line Optimization
11/20/2025
Bristol Myers Squibb's high-throughput stable CHO platform produces high-titer, high-quality material in a fraction of the conventional timeline.
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How To Grow CHO Cells Without Cysteine, Tyrosine Feeds
9/19/2025
Researchers at Pfizer are developing a cell line that synthesizes these amino acids autonomously, which could reduce costs and increase stability.
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Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification
7/1/2025
A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.
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Why 'Which Is Best?' Is The Wrong Question In CGT Development
6/27/2025
In cell therapy development, the instinct to seek a single “best” option is natural — but in reality, there’s rarely a universal winner.
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Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements
6/6/2025
This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.